The Realtime Detection for Individual Variation of Analgesic :A Comparison of Sufentanil vs Fentanyl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01748071
First received: December 9, 2012
Last updated: September 22, 2013
Last verified: September 2013

December 9, 2012
September 22, 2013
June 2012
December 2012   (final data collection date for primary outcome measure)
  • Mean Pressure Pain Threshold [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]
    According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
  • Mean Value of Narco-trend Index [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]
    According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.
  • Rangeability of pressure pain threshold [ Time Frame: 5 month ] [ Designated as safety issue: Yes ]
    According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics
  • Rangeability of Nacro-trend index [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of Nacro-trend index before and after intravenous injection of opioid analgesics
Complete list of historical versions of study NCT01748071 on ClinicalTrials.gov Archive Site
  • Mean Arterial Pressure [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]
    According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics
  • Mean Heart Rate [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]
    According to the measurement of heart rate before and after intravenous injection of opioid analgesics
  • Mean Respiratory Frequency [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: Yes ]
    According to the measurement of respiratory frequency after intravenous injection of opioid analgesics
  • Rangeability of Ramsay Sedation Scale [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics
  • Rangeability of mean arterial pressure [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics
  • Rangeability of heart rate [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of heart rate before and after intravenous injection of opioid analgesics
  • Rangeability of respiratory frequency [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics
Not Provided
Not Provided
 
The Realtime Detection for Individual Variation of Analgesic :A Comparison of Sufentanil vs Fentanyl
Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics

Purpose: This study aimed to find a quick and timely way to investigate the individual variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries. Methods: 120 female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

120 Chinese female patients receiving elective surgery under general anesthesia

  • Surgery
  • Individuality
Not Provided
  • Sufentanil group
    Grouped by intravenous injection of sufentanil at the time of anesthesia induction
  • Fentanyl group
    Grouped by intravenous injection of fentanyl at the time of anesthesia induction
  • Saline group
    Grouped by intravenous injection of saline before the time of anesthesia induction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 20-65 years
  • Anesthesiologists (ASA) physical status I or II;
  • Within ±20% of ideal body weight;
  • Agreed to participate the research

Exclusion Criteria:

  • History of chronic pain;
  • Psychiatric diseases;
  • Diabetes mellitus;
  • Severe cardiovascular diseases;
  • Kidney or liver diseases;
  • Alcohol or drug abuse (according to the criteria of DSM-IV);
  • Pregnancy or at lactation period;
  • Disagree to participate to the research
Female
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01748071
Individual Variation
Yes
Xianwei Zhang, Huazhong University of Science and Technology
Huazhong University of Science and Technology
Not Provided
Study Director: Zhang Xianwei, MD Huazhong University of Science and Technology
Huazhong University of Science and Technology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP